Will physicians prescribe apps in the not-too-distant future? Would payers subsidize or cover smartphones in the future to encourage patients to use mobile health tools? What should the criteria be for a mobile health app certification program for hospitals? What criteria should determine whether an app is worth having in a hospital formulary?
These are the questions the CEO of the mobile health store Happtique has been considering as the company nears two milestones. This summer physicians will be testing its prescription app program in a nationwide pilot. The pilot will focus on doctors treating heart disease, diabetes and musculoskeletal conditions as well as physical therapists and trainers. Also, the company will post its app certification guidelines for public review on its website next month. Happtique is a spinout of the Greater New York Hospital Association’s venture arm.
Happtique’s move comes ahead of formal guidelines from the U.S. Food and Drug Administration that are expected to tighten guidelines for mobile health apps that go beyond simple health and fitness tracking.
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App certification criteria
It formed a certification board earlier this year of clinicians, nurses and patient advocate Dave deBronkart, also known as e-Patient Dave, and is on the cusp of submitting a draft of the certification process for public review. Although Happtique has availed itself of GNYHA’s relationships with hospitals and clinicians to help inform and improve its solutions, none of Happtique’s app management, curation, or certification programs were created expressly for the GNYHA membership. Its “formulary” platform is available to hospitals around the country.
“We don’t see anyone else developing prescribing technology,” said Happtique CEO Ben Chodor. “We don’t want to be a ratings agency, but after a number of physicians start using it, we’ll know which apps are the most used.”
Institutions need a way to cut through the clutter, Chodor says. Hospitals don’t need 250 blood glucose monitors, although he emphasizes there is no magic number for apps by treatment category. A certification program will lead to developers building more compelling apps for the marketplace.
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“From where I’m sitting, the greatest part of this space is the amazing technology being created to push healthcare delivery in a new direction. On the other side of the space, we’ve sort of got the wild, wild West. There’s a lot of excitement around app creation but few, if any, best practices or standards, which makes it particularly difficult for clinicians and patients to select apps from the literally tens of thousands in the marketplace. That’s one of the big roles Happtique is working to fill: helping clinicians and patients sort and select apps and then facilitate app adoption into real world patient care.”
Under the current draft of the certification rules, an app owner would include technical and content details in its application. The apps will be reviewed for functionality, privacy and security standards before getting appraised on consistency and whether the app does what its developer says it does. Although efficacy and outcomes are not part of the current criteria, it would take that information into consideration if the app has been through a clinical trial.
Some apps have been through clinical trials and received 510(k) clearance from the FDA as a medical device. Chodor views the certification program as an easier way to accomplish a similar goal.
An app for prescribing apps
For the prescription app pilot, the main criteria included being easy to use for physicians with a minimum number of clicks to avoid interfering in their workday. It also needed to have back end technology that’s intuitive, with the ability to look up reimbursement down the road.
But if healthcare has gotten to the point where physicians are prescribing apps, will payers start covering the cost of smartphones or subsidize them? Chodor thinks it’s possible if mobile health apps help people reduce hospital visits and improve the quality of patient-physician interactions.
Chodor says he is pleased with the reception his program is getting from government regulators and medical organizations like the American Medical Association, Federal Communications Commission and Federal Trade Commission and FDA, as well as from hospitals.
“Over the past four to five months I think the healthcare marketplace has really started to recognize the huge potential of mhealth,” he said. “Certainly there have been thought leaders in this field for awhile, but I think hospitals and clinicians more broadly have started to use apps, create apps and are really seeing innovative ways to use mhealth to improve and change healthcare delivery and patient engagement.”
Physicians interested in participating in the pilot program for Happtique’s prescription app program mRx, should contact [email protected]. Applications will be posted on the company’s website. Chodor also co-hosts an Internet radio program on mobile health-related issues called mhealth zone.
